Bovilis Blue-8

bluetongue virus vaccine, serotype 8 (inactivated)

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This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8.It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Bovilis Blue-8.

For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

What is Bovilis Blue-8 and what is it used for?

Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges. Clinical signs of the disease include fever, skin ulceration, as well as swelling and occasionally blueish discolouration of the tongue mainly seen in sheep. The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle. The vaccine contains inactivated (killed) bluetongue virus, serotype 8.

This medicine is the same as Bluevac BTV8, which is already authorised in the EU. The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent’).

How is Bovilis Blue-8 used?

The vaccine is available as a suspension for injection and can only be obtained with a prescription.

The vaccine is given to cattle and sheep as two injections under the skin. The first injection is given from two and a half months of age and a second injection is given three weeks later. For booster vaccination a single injection is given every year. Protection starts 31 days after the second injection in cattle and 20 days after the second injection in sheep. Protection lasts for one year.

How does Bovilis Blue-8 work?

Bovilis Blue-8 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease. When it is given to cattle and sheep, the animals’ immune system recognises the virus as ‘foreign’ and produces antibodies against it. In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to stimulate a better reaction by the immune system.

What benefits of Bovilis Blue-8 have been shown in studies?

The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age. The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection. In all studies the vaccinated sheep and cattle were compared with unvaccinated animals (controls). The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8.

What are the risks associated with Bovilis Blue-8?

The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days.

For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

No special precautions are required.

What is the withdrawal period in food-producing animals?

The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. It is also the time required after administration of a medicine before milk may be used for human consumption.

The withdrawal period for meat and milk from cattle and sheep treated with Bovilis Blue-8 is ‘zero’ days, which means there is no mandatory waiting time.

Why is Bovilis Blue-8 approved?

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Other information about Bovilis Blue-8:

The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017. This authorisation was based on the authorisation granted to Bluevac BTV8 in 2011 (‘informed consent’).

For more information about treatment with Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.

Name Language First published Last updated
Bovilis Blue-8 : EPAR - Summary for the public BG = bălgarski 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public ES = español 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public CS = čeština 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public DA = dansk 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public DE = Deutsch 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public ET = eesti keel 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public EL = elliniká 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public EN = English 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public FR = français 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public IT = italiano 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public LV = latviešu valoda 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public LT = lietuvių kalba 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public HU = magyar 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public MT = Malti 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public NL = Nederlands 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public PL = polski 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public PT = português 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public RO = română 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public SK = slovenčina 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public SL = slovenščina 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public FI = suomi 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public SV = svenska 2017-12-08  
Bovilis Blue-8 : EPAR - Summary for the public HR = Hrvatski 2017-12-08  

This EPAR was last updated on 08/12/2017 .

Authorisation details

Product details

Product details for Bovilis Blue-8
NameBovilis Blue-8
Agency product numberEMEA/V/C/004776
Active substance

bluetongue virus vaccine, serotype 8 (inactivated)

International non-proprietary name (INN) or common name

bluetongue virus vaccine, serotype 8 (inactivated)

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI04AA02


Publication details

Publication details for Bovilis Blue-8
Marketing-authorisation holder

Intervet International B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/11/2017

Contact address:

Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

Product information

Product information

21/11/2017  Bovilis Blue-8 -EMEA/V/C/004776

Name Language First published Last updated
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - Product Information HR = Hrvatski 2017-12-08  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  
Bovilis Blue-8 : EPAR - All Authorised presentations HR = Hrvatski 2017-12-08  

Pharmacotherapeutic group

Immunologicals for ovidae

Therapeutic indication

Sheep

For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.

Cattle

For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.

*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Bovilis Blue-8 : EPAR - Public assessment report HR = Hrvatski 2017-12-08  
CVMP summary of positive opinion for Bovilis Blue-8 HR = Hrvatski 2017-09-08  

Authorised

This medicine is approved for use in the European Union